The present invention relates to record and verify systems used in medical and other healthcare settings, and, more particularly, to improved record and verification systems and methods for such use which include a number of important features and advantages as compared with prior art systems and methods, including those currently in use.
By way of background, it is instructive to briefly consider the history of verify and record systems used in connection with radiation therapy treatment of patients using linear accelerators or other megavoltage radiation units. Verify and record systems were originally designed to verify that radiation treatments were set up correctly by the radiation therapy technologist (RTT). This was accomplished through verification that certain key parameters were within predetermined tolerances. The verify and record process has evolved more recently into an automated set-up procedure that emphasizes rapid through-put, while de-emphasizing verification of treatment parameters that previously were set manually by the RTT. Some record and verify systems currently in use actually take control of the manual process by changing physician-selected field sizes, even though the field sizes fall within selected tolerance limits. The trend toward automated systems has led to reduced interaction between the user and the accelerator which has both positive and negative implications. The philosophy of delivering radiation treatment based on an automated set-up model is grounded in the desire to reduce the potential for human error in the set-up process. The downside of the automated or xe2x80x9cblack boxxe2x80x9d approach is the disengagement of the RTT from parameter adjustment, i.e., in relieving the RTT of the task of setting the patient treatment parameters through adjustment of the linear accelerator. The negative aspect of this is that if the RTT does not have to set the parameters manually, the RTT is less conditioned to perform the function manually and, therefore, less conditioned to detect errors when these errors occur, whether these errors are dosimetry programming or process errors and whether these errors occur in manual or automated set-up modes. When the RTT is detached from the procedure of manually setting up the patient for treatment, it becomes more difficult for the overall treatment process to recover should the automated process fail. In this regard, when an RTT sets up a patient manually, the RTT xe2x80x9crehearsesxe2x80x9d the recovery procedure that would be used if the automated primary process should fail. However, when automated set-ups are employed, the RTT is less xe2x80x9crehearsedxe2x80x9d in recovering efficiently when the automated process is not available, because such rehearsal of recovery procedures is not integral to automated treatment delivery. The more safety critical the task, the more the recovery should be rehearsed.
Given current trends in the medical industry, the trend toward automated set-up is irreversible. Further, because of a number of factors including cost pressures, the trend toward staffing reduction is irreversible, at least in the near term. It also appears clear that the electronic record will not totally replace the paper chart, at least not in the near term. In this regard, even if it were proven better for patient care to chart electronically, physician resistance will hinder widespread adoption in the foreseeable future. In general, physicians will not abandon paper charts, either from habit or for medical-legal reasons. Accordingly, the need for maintaining a paper record during implementation of electronic medical record keeping will continue. As a consequence, a further vulnerability of automated radiation treatment systems (in addition to the disengagement of the RTT from the manual recovery process when the automated system is temporarily down), is the potential for mismatches between the electronic record and the paper medical record. These mismatches are commonly due to a failure of the RTT to document treatments in the paper record when the automated system logs the event. The problem of electronic record and paper mismatches is increasing in the specialty of radiation oncology, as reported by clinical medical physicists.
It should be understood that disengagement of the RTT from the manual recovery process increases risk for patient care because the verify and record systems, in many recent configurations, do not check for human error. Record and verify systems, when programmed and executed correctly, can prevent some errors, but not all. Record and verify systems in current use cannot detect human errors when the system itself is the primary process. Additionally, as indicated above, the disengagement of the RTT from linear accelerator parameter adjustment also can disengage the RTT from subtle cues regarding patient identification and radiation field placement. It would be desirable if record and verify systems were configurable to allow automated set-ups at selected times for certain radiation therapy technologists and not for others, such as, for example, when the manual skills of selected RTTs are being assessed. However, the overall trend is clearly toward automated set-up because of the improved throughput which results, as well as the industry-wide momentum toward multi-leaf collimator therapy, which is more optimally performed with automation.
Greater automated throughput can lead to greater risk for other reasons as well. Increased automation means greater potential for a mistake occurring through dose calculation error, with the danger of the error being repeated without prompt detection once the error does occur. The emphasis on throughput also increases the probability of errors in the actual treatment process, characterized by patient identification errors, field sequence errors and field alignment errors. Major preventable ways to harm patients through treatment process failures include (1) treating the wrong patient, i.e., treating a patient with a radiation treatment intended for another patient; (2) treating the right patient, but on a day when the patient is not supposed to receive treatment until other evaluations are performed first (e.g., treating a patient when the patient should have been seen by the doctor prior to the treatment delivery), and (3) treating the right patient but with the improper treatment set-up, i.e., treating with a wedged field without a wedge, treating with the wrong monitor units (MU) programmed into the accelerator, or treating with the wrong energy. In addition, as described above, in the event that the record and verify device should be temporarily unavailable due to a network, or other, problem, there is a distinct possibility or even an increased probability of parameter selection errors due to human error, because the process of automation can change the behavior of the user, making the user more dependent on automation. It is noted that more combination chemotherapy with radiation increases toxicity and therefore increases the potential harm that may occur to a patient if the patient receives the wrong treatment or if the patient is treated without proper evaluation before treatment. Moreover, pushing patients to the limit of tissue tolerance increases the potential for adverse events. Automated treatment may increase the possibility of undetected mistakes related to automated set-up, thereby increasing the possibility of patient injury.
As indicated above, the transition to automated treatment system tends to distract the RTTs for a number of reasons. First, and very basically, the new technology creates a new process. Further, the new process diverts RTTs from traditional cross checks in the treatment room. This is true of systems now in use such as the VARIS, IMPAC and LANTIS systems. In addition, visual distractions are created and the RTTs are diverted from paper chart documentation which can be critical in the safe treatment of a patient.
Although the focus above has been on radiation therapy, it will be appreciated that similar problems exist in other medical treatment and healthcare settings including chemotherapy as well as in neonatal care, dispensing of medications on both an inpatient and outpatient basis, nursing care and other healthcare in nursing homes, and in other inpatient and outpatient applications wherein patient verification, medication verification, medication delivery device verification, healthcare delivery verification and the like are of importance.
According to the invention, methods, devices and systems are provided which ameliorate or overcome a number of important problems associated with methods and systems currently in use as is discussed in more detail below.
In accordance with one aspect of the invention, there is provided a record and verify method for use in monitoring healthcare administered to a patient, the method comprising the steps of:
(a) initially entering, into a computer monitor, data corresponding to the healthcare to be administered;
(b) verifying the patient healthcare data entered into the computer monitor against at least one source;
(c) entering data from the computer monitor into a paper verification sheet;
(d) administering the healthcare to the patient; and
(e) updating a patient record after the healthcare has been administered.
Preferably, the step of updating a patient record comprises making an entry into the computer that the healthcare has been administered.
Advantageously, the method further comprises checking and signing the paper verification sheet. The step of updating a patient record preferably comprises making an entry into the computer that the healthcare has been administered and the step of checking and verifying the paper verification sheet is carried out after said entry.
In one preferred implementation, the data corresponding to the healthcare to be administered that is entered into the computer monitor is previously stored and is automatically downloaded into the computer monitor at the request of an operator.
In another preferred implementation, the data corresponding to the healthcare to be administered is entered into the computer monitor from a patient healthcare administration chart.
In one preferred embodiment, the method is used with a radiation therapy treatment system including a radiation treatment device for providing radiation treatment and the computer monitor comprises a radiation treatment monitor and an associated computer for monitoring the radiation treatment device. Further, the healthcare data comprises radiation treatment data and the radiation treatment data is entered into the treatment monitor from a patient treatment chart and the step of administering healthcare comprises using the radiation treatment device in treatment of the patient. The step of using the radiation treatment device generates actual treatment data, and the step of updating a patient record preferably comprises entering said actual treatment data into the patient treatment chart, and the method preferably comprises the further step of: (f) checking and signing (e.g., by initialing and dating) the data entered into the patient treatment chart and into the paper verification sheet.
In one preferred implementation of this embodiment, first and second radiation therapists carry out the method, and the first therapist is responsible for at least step (e), the second therapist is responsible for at least steps (b) and (c) and both therapists carry out, and are responsible for, step (f). Preferably, after treatment data is entered into the treatment monitor and the data entered is displayed on a monitor screen associated with the treatment monitor, the first therapist recites aloud selected treatment data from the patient treatment chart and the second therapist verifies the recited treatment data against the data entered into treatment monitor as displayed on said monitor screen. Advantageously, the second therapist verbally recites the treatment data displayed on said monitor screen. Preferably, both the first and second therapists initially view, on a monitor screen associated with the treatment monitor, treatment data entered into the treatment monitor, the first therapist then recites aloud selected treatment data from the monitor screen, the second therapist, while still viewing the monitor screen, verifies the selected treatment data, in real time, as recited by the first therapist, the second therapist, while still viewing the monitor, recites aloud the preselected treatment data from the monitor screen, the first therapist, when still viewing the monitor screen, verifies the preselected treatment data, in real time, as recited by the second therapist, and the second therapist then enters the preselected treatment data into the paper verification sheet.
In a further preferred implementation of this embodiment, only selected treatment data, of the patient treatment data that is entered into the treatment monitor, is entered into the paper verification sheet. Advantageously, the selected treatment data consists of the (i) presence or absence of a wedge, (ii) the energy level used, and (iii) the monitor units used.
In another preferred implementation of this embodiment, wherein multiple radiation fields are delivered to the patient, steps (a) to (e) above are repeated for each field, and the method further comprises entering of a cumulative radiation dose into the patient treatment chart when all of the multiple treatment fields have been delivered.
In accordance with a further aspect of the invention there is provided a method for use in carrying out a medical treatment wherein a computer and a computer monitor including a monitor screen are used at least in setting up of the medical treatment, the method comprising:
setting a time period in which at least one action requiring interfacing with the monitor must be carried out;
monitoring whether the at least one action has been carried out during said time period; and
if the at least one action is not carried out within said time period, at least temporarily providing that the medical treatment is not to proceed.
In a first preferred implementation, the step of at least temporarily providing that the medical treatment is not to proceed comprises providing that the at least one action must be carried out within a new time period before the medical treatment can proceed.
In another preferred implementation, the step of at least temporarily providing that the medical treatment is not to proceed comprises blanking out the monitoring screen.
In yet another preferred implementation, the step of at least temporarily providing that the medical treatment is not to proceed comprises providing a prompt on the monitor screen which requires a predetermined reply before the medical treatment is to proceed.
In one preferred embodiment of the first implementation, the at least one action comprises at least two separate actions, each with a separate time period for completion. In another embodiment, the at least one action comprises at least two actions both of which must be completed within said period. In an embodiment wherein the medical treatment includes the use of a treatment unit controlled by the computer and monitor, the step of at least temporarily providing that the medical treatment is not to proceed if the at least one action is not completed during said time period comprises prohibiting use of the treatment unit. Advantageously, use of the treatment unit is prohibited by disabling the monitor.
Preferably, the at least one action comprises (i) scanning of an identifier member, including a patient identifier, using an optical scanner associated with the computer monitor, and (ii) scanning of a patient treatment sheet, including said patient identifier, using said optical scanner, and use of said treatment unit is prohibited if either said scanning is not carried out during said time period. In an advantageous implementation, a characteristic audio signal, previously assigned to the patient undergoing the medical treatment and unique to the patient, is generated for each said scanning wherein the patient identifier matches an identifier for the patient stored by said computer. Preferably, when each said scanning is successfully completed, a further predetermined time period is started for use of said treatment unit, and use of said treatment unit is prohibited at the end of said further period. Advantageously, after use of said unit is prohibited, the computer monitor displays a query on the monitor screen as to whether treatment is continuing and, in response to entry of a positive reply, enables the treatment unit. Preferably, when use of said unit is prohibited, the monitor displays on the monitor screen a query requesting confirmation that the patient treatment sheet has been updated. In one important embodiment, the at least one action further comprises scanning of an identifier by at least one treatment practitioner within a predetermined time period prior to said scanning of the identifier member and the patient treatment sheet.
In a preferred embodiment of each implementation, the at least one action comprises scanning of an identifier by an optical reader associated with said computer monitor. In one specific embodiment, the identifier is carried by a medical instrument. In an advantageous implementation, the medical treatment comprises delivery of a drug and the medical instrument is a syringe. In another specific embodiment, the identifier comprises a patient photograph. In yet another embodiment, the identifier is associated with identifying member for one of (i) a patient undergoing the medical procedure and (ii) at least one treatment practitioner.
In all implementations of the method in accordance with this aspect of the invention, the at least one action preferably comprises providing identification of one of (i) a patient to be treated and (ii) at least one treatment practitioner, and the identification is provided by reading of an identifier by an optical reader associated with said control monitor.
In accordance with yet another aspect of the invention, there is provided a method for use in carrying out a medical procedure, using a treatment unit and a computer and monitor for controlling the treatment unit, so as to ensure that at least one action, requiring interfacing with the monitor, is completed in a timely manner, said method comprising:
initiating at the monitor, a start time for the at least one action to be carried out;
determining whether the at least one action has been carried out within a predetermined time period after said start time; and
at least temporarily preventing access to the treatment unit if the at least one action has not been carried out within said predetermined period.
According to still another aspect of the invention, a check sheet is provided for use in administration of patient healthcare, the check sheet containing (i) entry spaces for entry by a healthcare caregiver of healthcare parameters for verification, and (ii) headings for the entry spaces each identifying a corresponding healthcare parameter, said healthcare parameters consisting of no more than three parameters excluding parameters relating to the time of administration of the healthcare.
Preferably, the check sheet further includes a heading for the time of day at which the patient healthcare is administered.
In one important implementation, the check sheet comprises a treatment check sheet for a patient undergoing radiation treatments, the treatment check sheet listing a plurality of treatment parameters for entry of data for verification by at least one radiation treatment practitioner prior to administration of a radiation treatment, said treatment parameters consisting solely of three patient specific parameters. Preferably, the three parameters consist of wedge presence, radiation energy level and monitor units. Advantageously, the treatment check sheet includes four rows or columns thereon, said rows or columns including headings and, following each of said headings, a plurality of empty spaces for entries by the treatment practitioner, said headings including wording indicating that the corresponding column is designated for entries with respect (i) the current date, (ii) the radiation energy level, (iii) the presence or absence of a wedge and (iv) monitor units. Preferably, the treatment check sheet includes at least one place thereon designated for checking off by a treatment practitioner using the treatment check sheet.
In accordance with yet another aspect of the invention, there is provided a method of assisting in full completion of a medical procedure for an individual patient undergoing the medical procedure, the method comprising:
assigning an audio signal to a patient and ensuring that the patient recognizes the assigned audio signal when said audio signal is generated;
generating said audio signal at a treatment site during the medical procedure so that the signal is heard by the patient;
providing for terminating of the audio signal only after treating personnel performs at least preselected action necessary to properly conclude the medical procedure; and
instructing the patient to remain at the treatment site until the audio signal is terminated.
Preferably, the audio signal comprises a piece of music, the piece of music is played while the patient is on a treatment table, and the at least one action comprises updating of a treatment record for the patient.
According to a further aspect of the invention, there is provided a record and verify method for use with a radiation therapy system including a radiation treatment device for providing radiation treatment and a treatment monitor, including a computer, for monitoring the treatment provided by the radiation treatment device, the method comprising the steps of:
initially entering, into the treatment monitor, patient treatment data corresponding to that contained in a patient treatment chart;
verifying patient treatment data entered into the treatment monitor against at least one source;
entering treatment data from the treatment monitor into a paper verification sheet;
cross checking the treatment data entered into said paper verification sheet;
using the radiation treatment device in treating of the patient; and
updating the patient treatment chart after said treating of the patient.
In accordance with yet another aspect of the invention, there is provided a record and verify method in monitoring the administration of a patient care intervention, the method comprising the steps of:
initially entering, into a computer including an associated monitor screen, data corresponding to the patient care intervention that is to be administered to a patient;
accessing the computer by presenting to an optical detector associated with the computer an identifier corresponding to an identifier stored by the computer so that when there is a match between the presented identifier and the stored identifier, at least some of said entered data is displayed;
administering a patient care intervention to the patient corresponding to the entered data displayed on the monitor screen;
entering into a paper verification sheet selected data related to the patient care intervention administered to the patient; and
making an entry into the computer that the patient care intervention has been administered.
According to a further aspect of the invention, there is provided a record and verify method for use in monitoring a medical treatment administered to a patient, the method comprising the steps of:
initially entering patient treatment data corresponding to that contained in a patient treatment chart into a computer including an associated monitor screen;
verifying patient treatment data entered into the computer and appearing on the monitor screen against at least one source;
entering selected treatment data from that appearing on the monitor screen of the treatment monitor into a paper verification sheet;
cross checking the treatment data entered into the paper verification sheet;
carrying out the treatment; and
entering into the patient treatment chart (i) an indication that the treatment has been carried out and (ii) an indication of any differences between the treatment data entered into the paper verification sheet and any actual treatment data.
Preferably, the computer includes an associated optical detector and access to the computer is effected by presenting to the optical detector an identifier member carrying an identifier matching an identifier stored by the computer.
According to still another aspect of the invention, there is provided a record and verify method for monitoring a patient care intervention administered to a patient, said method comprising the steps of:
entering critical data received relating to a patient care intervention, along with the name of the patient and the time and date, into a pre-prepared paper log sheet;
verifying the critical data entered with at least one source;
carrying out the patient care intervention;
entering data relating to the patient care intervention into a computer monitor; and
checking off on the paper log sheet that the data has been entered into the computer monitor.
Preferably, if the patient care intervention is not carried out or is not fully carried out, the method further comprises marking the log sheet to indicate this.
In accordance with still another aspect of the invention, there is provided a document carrier for healthcare documents, the document carrier comprising:
a first, backing member;
a second, transparent member affixed to said backing member so as to form a first pocket for the receipt of healthcare documents; and
a third, transparent member affixed to the second member and forming a second, partial pocket for temporary receipt of at least one healthcare document normally received in said first pocket, said second pocket being easier to access and providing less secure holding of documents than the first pocket.
Preferably, the document carrier further comprises a transparent pocket member affixed to said second member in an area thereof separate from the third member. Advantageously, the pocket member comprises front and back walls selectively secured together along facing edges thereof to form a pocket having an upper opening between said walls, the back wall being secured to the second member. In a preferred embodiment, the first pocket contains a log sheet and a guide sheet, the log sheet is disposed adjacent the second member and carries a machine readable, patient specific identifier which is machine readable through said second member and the pocket member contains a patient identification element carrying a machine readable, patient specific identifier which corresponds to the patient specific identifier carried by said log sheet and which is machine readable through said front wall of said pocket member.
In a preferred implementation, the third transparent member is triangular in shape and is attached at two side edges thereof to said second transparent member. Advantageously, the two side edges are affixed to said second member by heat sealing, the side edges comprise a lateral edge and a bottom side edge and the lateral edge has a length of at least 7 inches.
According to a further embodiment, there is provided a record and verify method for monitoring a caregiver intervention, the method comprising:
providing an electronic presentation of an inquiry as to whether a particular patient intervention administered by a caregiver is best characterized as full, partial or none;
prompting the caregiver to provide a simple response to the inquiry; and
recording the response of the caregiver to the inquiry for future use.
Preferably, the inquiry is presented in a dialog box on touch sensitive computer screen and the caregiver responds by touching an appropriate screen location.
Further features and advantages of the present invention will be set forth in, or apparent from, the detailed description of preferred embodiments thereof which follows.